VICHY LABORATOIRES NORMADERM SOS ACNE RESCUE SPOT CORRECTOR- sulfur lotion

Vichy Laboratoires Normaderm SOS Acne Rescue Spot Corrector by

Drug Labeling and Warnings

Vichy Laboratoires Normaderm SOS Acne Rescue Spot Corrector by is a Otc medication manufactured, distributed, or labeled by L'Oreal USA Products Inc, Englewood Lab, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Sulfur 10%

Purpose

Acne treatment

Use

for the treatment of acne

Warnings

For external use only

Do not use on

• broken skin
• large areas of the skin

When using this product

• skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time. If irritation occurs, only use one topical acne medication at a time.
• apply only to areas with acne

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

• clean the skin thoroughly before applying this product
• cover the entire affected area with a thin layer one to three times daily
• because excessive drying of the skin may occur, start with one application daily, then gradually increase to two or three times daily if needed or as directed by a doctor
• if bothersome dryness or peeling occurs, reduce application to once a day or every other day

Inactive ingredients

water, niacinamide, zea mays (corn) starch, glycolic acid, stearyl alcohol, glycerin, octyldodecyl myristate, cetearyl alcohol, glyceryl stearate, sodium hydroxide, magnesium aluminum silicate, PEG-100 stearate, c13-14 isoparaffin, allantoin, ceteareth-20, phenoxyethanol, phenylethyl resorcinol, tocopheryl acetate, disodium EDTA, laureth-7, hydrogenated lecithin, polyacrylamide, ethylhexylglycerin

Questions or comments?

1-877-378-4249

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

VICHY LABORATOIRES NORMADERM SOS ACNE RESCUE SPOT CORRECTOR 
sulfur lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49967-648
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70)	SULFUR	100 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
NIACINAMIDE (UNII: 25X51I8RD4)
STARCH, CORN (UNII: O8232NY3SJ)
GLYCOLIC ACID (UNII: 0WT12SX38S)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
GLYCERIN (UNII: PDC6A3C0OX)
OCTYLDODECYL MYRISTATE (UNII: S013N99GR8)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)
PEG-100 STEARATE (UNII: YD01N1999R)
C13-14 ISOPARAFFIN (UNII: E4F12ROE70)
ALLANTOIN (UNII: 344S277G0Z)
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
PHENYLETHYL RESORCINOL (UNII: G37UFG162O)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
EDETATE DISODIUM (UNII: 7FLD91C86K)
LAURETH-7 (UNII: Z95S6G8201)
HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)
NYLON-12 (UNII: 446U8J075B)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49967-648-01	1 in 1 CARTON	12/01/2020
1		20 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M006	12/01/2020

Labeler - L'Oreal USA Products Inc (002136794)

Establishment
Name	Address	ID/FEI	Business Operations
Englewood Lab, Inc.		172198223	manufacture(49967-648)